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December 12, 2007 News for medical technology professionals   Top Story    Top scientific advances of 2007 The TIME magazine list of the top 10 scientific discoveries for 2007 featured stem cell research breakthroughs in the No. 1 spot, highlighting research that reprogrammed skin cells to serve as stem cells and the cloning of monkey embryonic stem cells. The top 10 also included the complete mapping of J. Craig Venter's genome and the creation of functioning human heart-valve tissue from bone marrow stem cells. TIME (12/11) Top medical advances of 2007: TIME magazine offered the top 10 medical breakthroughs of 2007, with male circumcision as a preventive measure for HIV at No. 1 on the list. Other advances highlighted include the GeneSearch BLN Assay test for metastatic breast cancer, the first human vaccine for bird flu and the Alli weight-loss drug. TIME (12/11) White Paper: What is the Essence of Quality Beyond CAPA? – This free, informative paper from Camstar and Axendia examines and makes the case for going beyond traditional Quality Management systems (CAPA, Complaint Handling, Audit etc) to the essence of quality: fundamental understanding and control of manufacturing processes. Download here.   Business & Market Trends    Inverness Medical to acquire BBI Holdings for $170M Waltham, Mass.-based Inverness Medical Innovations has signed a deal to buy U.K.-based BBI Holdings PLC for about $170 million. BBI's expertise in lateral flow based rapid diagnostic products will complement Inverness' existing business, Inverness' CEO said. American City Business Journals/Boston (12/11), The Wall Street Journal (tiered subscription model) (12/11) Judge rules in favor of J&J unit in patent suit with Medtronic A federal judge upheld a September ruling by a jury that orders Medtronic to pay $226.3 million to Johnson & Johnson's subsidiary DePuy Spine related to a patent-infringement suit involving spinal screws. A Medtronic spokeswoman said the company will appeal the decision. Star Tribune (Minneapolis-St. Paul, Minn.)/Associated Press (12/11) DOJ subpoenas documents from Wright Medical Arlington, Tenn.-based Wright Medical Group received a subpoena from the Department of Justice asking for documents from January 1998 to the present relating to its dealings with orthopedic surgeons over hip- and knee-replacement procedures and devices. The company said it will cooperate with the agency. The Daily News (Memphis, Tenn.) (12/11) Canadian reactor to resume medical-isotope production Atomic Energy of Canada Ltd. said its nuclear reactor could resume production of radioisotopes within days if the Canadian government succeeds in passing emergency legislation allowing AECL to use a back-up method. The shutdown of the reactor, which was due to technical problems, caused worldwide shortages in medical isotopes for cancer tests. Yahoo!/Reuters (12/11) Requests by FDA likely to delay Cyberkinetics nerve-growth stimulator The FDA has asked Cyberkinetics Neurotechnology Systems to provide additional analyses and data on Andara, its implantable device that stimulates nerve growth in patients with acute spinal-cord injuries, before it grants a humanitarian device exemption for the product. The agency's additional requests are expected to delay the approval of the device until the first half of next year, the company said. American City Business Journals/Boston (12/11) Become more competitive, expand your business advantage and drive innovation through technology. Learn how to better respond to marketplace needs and deliver real business value. View our white papers and listen to our podcasts to learn how to accelerate delivery of new products, speed time-to-market and grow your business.   Science & Health  Study reveals inconsistencies in reading diagnostic mammograms A U.S. study found that radiologists failed to detect 21% of breast cancers in diagnostic mammograms and also found a variation in false-positive results. Women should go to diagnostic centers with breast-imaging experts, a researcher said. Reuters (12/11) Risk factors predict candidates for total hip replacement People who are at least 60 years old and experiencing morning stiffness, decreased ability to extend the hip and specific pains are at risk for progressive hip osteoarthritis and total hip replacement, a new study revealed. Yahoo!/Reuters (12/11) Private medical scans raise concerns, U.K. expert says A British specialist said in a journal article that administration of private medical screening -- such as "full body MOTS," CT scans and blood tests -- to healthy people could cause anxiety and could raise the risk of cancer. The U.K. Department of Health plans to release a report on the issue next week. BBC (12/11) The Buzz(CORPORATE ANNOUNCEMENTS) White Paper: Using Automation to Support FDA Compliance The FDA issued over 6,000 483's and 535 warning letters in 2005. Do you want to prevent your organization from becoming a statistic, too? Request the regulatory white paper 21 CFR Part 820 - Learning to Navigate Standards & Address their Complexities, and discover how Pilgrim Software supports Medical Device manufacturers in their quest for compliance. Request Here How Is "Meta-Analysis" Changing Drug Safety? JUST RELEASED: Understanding The New Drug Safety Standards: The Emerging Science of Meta-Analysis. See what the experts are saying in this special report and Avandia case study from "The Pink Sheet". Find out more or call 800-332-2181. Interested in learning more about advertising in AdvaMed SmartBrief? Contact Meryl Harold at (202) 407-7828 or mharold@smartbrief.com.     Emerging Technologies  FDA OKs Zimmer mobile bearing knee The FDA has granted Zimmer Holdings approval to market NexGen, a mobile bearing knee designed to provide greater flexibility for patients. The company plans to launch the device next year. Reuters (12/11) Artificial heart pump shows promise for children with one ventricle U.S. scientists are developing an artificial heart pump that aims to extend the lives of children with only one ventricle. Researchers plan to conduct a trial in animals of a titanium prototype of the device powered by an electromagnetic motor, and hope to launch the product within five years. Rocky Mountain News (Denver) (12/12)   AdvaMed News  AdvaMed opposes additional cuts to Medicare-provided imaging services Noting the important role of diagnostic imaging in combating disease, AdvaMed President and CEO Stephen J. Ubl issued a statement opposing additional proposed reductions in Medicare payment for imaging services as Congress continues to work on Medicare legislation. He complimented the concern of 69 House members who signed a letter opposing additional cuts to imaging payments. Read AdvaMed's news release and the congressional letter. AdvaMed-MTLI helps you prepare for the regulatory process in 2008 with two great courses Gear up for your company's 2008 business by joining the first AdvaMed-MTLI course of the year, Jan. 22 and 23 in Orlando! "Complaints, MDRs, Reports of Removals and Corrections and Recalls" will teach you how to navigate the regulatory process for medical device reporting, complaint handling and corrective actions. Sign up now. AdvaMed-MTLI is offering this course in conjunction with "Integrating Your Complaint Handling System with CAPA and Management Review," Jan. 23 and 24 in Orlando. Preview this agenda. Register for both courses and save up to $200! Learn more about AdvaMed -> About AdvaMed  |  Join  |  Courses  |  Events  |  Newsroom Advanced Quality Assurance and Regulatory Affairs Engineer Hill-Rom Raleigh NC Manager of Product Engineering BD Franklin Lakes NJ Compliance Manager Hill-Rom Charleston SC   SmartQuote  There is no personal charm so great as the charm of a cheerful temperament." --Henry Van Dyke, author, educator and clergyman     Subscriber Tools       Print friendly format | Web version | Search past news | Archive | Privacy policy Advertise Account Executive:  Meryl Harold (202) 407-7828 Download Media Kit Job Board:  Celia Rothschild (202) 470-1159   Read more at SmartBrief.com A powerful website for SmartBrief readers including: Industry Home Readers' Choice Search Archive Who's Hiring? 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